Official Title
Therapies to Achieve Treatment Goals While Being Exposed to Hygiene and Distance Rules: Feasibility and Benefits of Digital Services During the COVID19 Pandemic (Anhand-COVID19)
Brief Summary

As a result of the pandemic, hygiene and distancing rules must be followed in Health care/ rehabilitation clinics to ensure the safety of patients and staff. This has led to extensive changes in the therapy processes, including a reduction in group sizes and maintaining distances within the groups, resulting in a reduction in the range of therapies available to individuals, since the number of employees remains unchanged and cannot be increased at will and in the short term due to the lack of qualified staff. In order for the treatment/rehabilitation goals to be achieved nonetheless, new forms of implementation of therapy programs must be developed in addition to organizational adjustments. Digitalization can be a significant support in this respect. The majority of patients in psychosomatic rehabilitation possess smartphones, meaning that the necessary infrastructure for the utilization of digital offers is available and can be used to the greatest possible extent. The use of digital measures within the therapeutic services supports the independence of the patients, as they can use the digital offers independently and flexibly in their own time. How should Health care/rehabilitation services be designed in light of the SARS-CoV-2 pandemic and which services have the potential to buffer future crises: What general recommendations can be derived for the design of such services for routine care? What are support measures to encourage social participation and return to work?

Detailed Description

In Germany, the SARS-CoV-2 pandemic represents a crisis with massive effects on health and
rehabilitation care. This crisis is not a short-term event but will also has longer-term
effects on health care service/rehabilitation. Necessary adjustments due to hygiene and
distance regulations include, for example, the reduction of group sizes and alternatives to
conventional service provision (= digital services, McNeary et al., 2020). How such offers
are perceived and accepted by patients and staff is crucial for the effect on the care.
Systematic research into the pandemic from the patient and employee perspective, its
consequences for procedures in rehabilitation clinics and for the implementation of the
necessary therapies is required in a timely manner in order to better understand and mitigate
the effects of the pandemic and to ensure the effectiveness of rehabilitation. This is the
aim of this project with a focus on digital services and their subjective usefulness.

Furthermore, the integration of such offers can mean that a therapist is not present during
the entire therapy, but that rehabilitants first learn the basics of a topic in self-study.
This is based on the principle of the "Flipped Classroom". (Rehab) Patients as well as
employees of the clinics are involved in the piloting of the survey instruments and the final
choice of outcome criteria as well as the derivation of possible applications (guidelines,
recommendations for rehabilitants).

In addition, the pandemic is negatively associated with equal participation of vulnerable
groups (e.g. persons with physical or psychological handicaps). In the case of medical
rehabilitation patients, particular occupational problems make equal participation and social
cohesion more difficult: problems such as long-term limited productivity or the threat of
exclusion from the labor market (pension for reduced earning capacity), negative employment
forecasts and experiences of previously limited social participation are in turn further
exacerbated by demographic change and the consequences of the COVID 19 pandemic. These
restrictions are also reflected in the increased experience of loneliness. To date, however,
there is a lack of a systematic understanding of these circular, dynamic processes and
low-threshold, effective approaches to action, effective approaches to action.

The following questions will be empirically investigated:

1. How are digital services evaluated regarding feasibility, acceptance and subjective
usefulness in light of the current situation?

2. Which characteristics of rehabilitants are related to the acceptance and subjective
usefulness of digital offers?

3. For which patients of rehabilitation is there a need for support in the use of digital
services to achieve rehabilitation goals?

4. Are there differences in perceived usefulness between services?

5. How do people in the welfare state and labor market with disabilities and impairments
(rehabilitants) perceive the consequences of the Covid 19 pandemic and the
transformation processes?

6. How effective are support measures with regard to communication for rehabilitants in
supporting equal participation?

7. How should support for equal participation be designed in the long term: What What are
the consequences for labor market and social policy?

The methodology uses a natural variation design within the Dr. Becker Clinical Group in order
to investigate the issues at the highest possible scientific level and to achieve reliable
results. The interventions consist of an online depression session as a "flipped classroom"
and/or an online lecture with socio-medical content, and/ or a tobacco cessation lecture,
which are combined in such a way that the differential effects can be evaluated. For this
purpose, a control group is included that does not participate in these interventions (but
receives the standard rehabilitation treatment programm). Furthermore, all groups voluntarily
receive patient training before rehabilitation with the content of setting "treatment goals"
as well as an invitation to pre- and post-surveys.

The survey methods are online surveys (before the treatment=pre (T1); end of treatment=post
(T2); end of treatment=post 12 weeks (T3)) by means of UniPark.

The main target variables are reported behavior and well-being (stress/burden of COVID-19
disease or probability of disease, limitations, quality of life, anxiety or depression;
pre-post comparison) as well as subjective need (pre) and benefit (post) of the digital
services. Further primary target variables are concentrated on social participation,
workability and return to work. The theoretical foundation for the selection of target
variables and constructs is the Carry-Over Action Model. The sample includes all
rehabilitands who undergo a psychosomatic rehabilitation in the hospitals. The planned sample
size of the rehabilitants is N = 2,000.

The feasibility is given by the use of an existing care system with cover letters from the
patients before the treatment. Possible disturbance variables such as affinity towards
technology (which could lead to a lower participation rate among participants with little
affinity towards technology) are controlled for and taken into account in the evaluation.
Gender and diversity are considered as covariates or moderators in the statistical models.

All data of the participants will be treated in accordance with the data security regulations
(DSGVO), good scientific practice and the ethical requirements. Furthermore, all patients are
informed about the project, ethics and data protection in a generally understandable way by a
cover letter from their clinic before the treatment. All project staff are obliged to comply
with the ethics guidelines and to maintain confidentiality. The pre- and post-data of the
patients are combined by means of a personal code, which does not allow any conclusion about
the participant.

The results of this study will show which digital implementation forms of therapy offers are
feasible in terms of benefit and acceptance and can thus contribute to the further
development of health care services and medical rehabilitation. This will create the
necessary evidence base to include digital offers in the classification of therapeutic
services and the therapy standards based on them and thus to establish them in routine care.
Furthermore, a guideline for the future integration of these services into the health care
services/rehabilitation process will be developed. Due to the standardized combination of
analogue and digital therapy parts, therapy goals can be achieved more efficiently on the
basis of the validated pedagogical concepts used and with the involvement of fewer human
resources. This is not only relevant during the SARS-CoV-2 pandemic, but also with regard to
the relevant shortage of qualified personnel. Furthermore, the research basis for digital
measures to support social support for social participation will be created. With these
findings, similar measures on other groups, for example, persons with disabilities or
limitations, can be researched.

Active, not recruiting
Psychosomatic Disorder
Psychological Distress
Psychological Stress
Psychological Disease
Psychological Disorder
Psychological Impairment
Psychological Disability
Psychological Adjustment
Psychological Adaptation
Communication
Health Care Seeking Behavior
Anxiety
Behavior, Health
Health Risk Behaviors
Healthy Lifestyle

Behavioral: Training session adressing information and health literacy

The training sessions are provided online and as alternative to face-to-face treatments which cannot be provided as before due to the safety regulations relating to Covid-19

Eligibility Criteria

Inclusion Criteria:

- Patients before the start of the treatment

- Selected by the clinic

- Invited to participate in the study

Exclusion Criteria:

- Inability to read and write

- Severe dementia

- unwillingness to participate in the study and to sign consent form

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Germany
Locations

Jacobs University Bremen gGmbH
Bremen, Germany

Sonia Lippke, Prof. Dr., Principal Investigator
Jacobs University Bremen

Jacobs University Bremen gGmbH
NCT Number
Keywords
health behavior change
Stress
eHealth
Digital Intervention
medical rehabilitation
clinic stay
MeSH Terms
COVID-19
Psychophysiologic Disorders
Stress, Psychological
Mental Disorders
Somatoform Disorders